U.S. patent application number 17/620561 was filed with the patent office on 2022-08-25 for packaging for pharmaceutical products.
The applicant listed for this patent is REP IP AG. Invention is credited to Nico ROS.
Application Number | 20220265515 17/620561 |
Document ID | / |
Family ID | |
Filed Date | 2022-08-25 |
United States Patent
Application |
20220265515 |
Kind Code |
A1 |
ROS; Nico |
August 25, 2022 |
PACKAGING FOR PHARMACEUTICAL PRODUCTS
Abstract
In a packaging for pharmaceutical products, comprising a primary
packaging for receiving a dose or several doses of a pharmaceutical
product, and a secondary packaging designed as a cardboard box in
which the primary packaging is received, the primary packaging is
arranged in an insulation shell having a latent heat storage
material.
Inventors: |
ROS; Nico; (Riehen,
CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
REP IP AG |
Zug |
|
CH |
|
|
Appl. No.: |
17/620561 |
Filed: |
June 23, 2020 |
PCT Filed: |
June 23, 2020 |
PCT NO: |
PCT/IB2020/055907 |
371 Date: |
December 17, 2021 |
International
Class: |
A61J 1/16 20060101
A61J001/16; B65D 77/04 20060101 B65D077/04; B65D 81/38 20060101
B65D081/38; B65D 85/42 20060101 B65D085/42 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 24, 2019 |
AT |
A 232/2019 |
Claims
1. Packaging for pharmaceutical products, comprising a primary
packaging for receiving a dose or several doses of a pharmaceutical
product, and a secondary packaging designed as a cardboard box in
which the primary packaging is received, characterized in that the
primary packaging is arranged in an insulation shell having a
latent heat storage material, the insulation shell being adapted in
shape to the primary packaging and resting flat on the primary
packaging.
2. The packaging according to claim 1, characterized in that the
insulation shell surrounds the primary packaging on all sides.
3. The packaging according to claim 1, characterized in that the
primary packaging is designed as a blister pack, ampoule, injection
ampoule or vial.
4. The packaging according to claim 1, characterized in that the
latent heat storage material contains or is formed by a phase
change material.
5. The packaging according to claim 4, characterized in that the
phase change material is selected from the group consisting of:
paraffin, esters, linear alcohols, ethers, organic anhydrides, salt
hydrates, water-salt mixtures, salt solutions and water-based
solutions, or mixtures thereof.
6. The packaging according to claim 4, characterized in that the
phase change material has a phase transition temperature of
3-10.degree. C.
7. The packaging according to claim 4, characterized in that the
phase change material is present in a dimensionally stable
enclosure or a plastic enclosure.
8. The packaging according to claim 4, characterized in that the
latent heat storage material comprises a carrier material which is
dimensionally stable at the use temperature, in which the phase
change material is distributed or arranged so that the latent heat
storage material is dimensionally stable in a temperature range
both below and above the melting point of the phase change
material.
9. The packaging according to claim 8, characterized in that the
latent heat storage material is dimensionally stable up to a
temperature of at least 5.degree. C. above the phase transition
temperature of the phase change material.
10. The packaging according to claim 8, characterized in that the
insulation shell is produced by injection molding the latent heat
storage material.
11. The packaging according to claim 1, characterized in that the
insulation shell is molded onto the primary packaging.
12. The packaging according to claim 1, characterized in that the
insulation shell has a modulus of elasticity of 1 to 3,000
N/mm.sup.2.
13. The packaging according to claim 1, characterized in that the
insulation shell has a heat-reflecting coating, a metallic coating
or a metal foil, on its outside.
14. The packaging according to claim 1, characterized in that the
cardboard box has a heat-reflecting coating, a metallic coating or
a metal foil, on its inner surface.
15. The packaging according to claim 13, characterized in that the
heat-reflecting coating is formed of a metallic, gas-tight coating
with an emissivity of <0.5.
16. The packaging according to claim 1, characterized in that the
insulation shell is held in the secondary packaging at a distance
from the secondary packaging on all sides in order to form an
insulation gap.
17. The packaging according to claim 16, characterized in that the
insulation gap is filled with a gas or is evacuated.
18. The packaging according to claim 16, characterized in that at
least one layer of a heat-reflecting film is arranged in the
insulation gap.
19. The packaging Packaging according to claim 16, characterized in
that the insulation gap has a thickness of <16 mm.
20. The packaging according to claim 16, characterized in that
spacer elements are arranged in order to hold the insulation shell
in the secondary packaging at a distance on all sides from the
secondary packaging.
21. The packaging according to claim 20, characterized in that the
spacer elements consist of the phase change material of the
insulation shell or are formed from cardboard elements.
22. The packaging according to claim 1, characterized in that a
temperature sensor or a temperature control strip is arranged in
the insulation gap, in the latent heat storage material, between
the latent heat storage material and the primary packaging or in
the primary packaging.
23. Packaging for pharmaceutical products, comprising a secondary
packaging designed as a cardboard box, in which a primary packaging
for receiving one dose or several doses of a pharmaceutical product
can be received, characterized in that the cardboard box contains
an insulation shell having a latent heat storage material which
encloses an interior space in which the primary packaging can be
arranged.
24. Use of a phase change material in an insulation shell for
temperature stabilization of a pharmaceutical product in a
cardboard box designed as secondary packaging.
Description
[0001] The invention relates to a packaging for pharmaceutical
products, comprising a primary packaging for receiving one dose or
several doses of a pharmaceutical product, and a secondary
packaging designed as a cardboard box, in which the primary
packaging is received.
[0002] Ready-to-use pharmaceutical products are usually first
packed or filled in blisters, vials, syringes or injectors. The
pharmaceutical products provided with primary packaging in this way
are then in many cases packed in small cardboard boxes which serve
as secondary packaging and on which the information required for
marketing is printed.
[0003] A large number of such products, which are
secondary-packaged by the manufacturer, are combined into larger
units for transport and these units are provided with transport or
freight packaging. In the case of temperature-sensitive
pharmaceutical products, the transport or freight packaging can be
provided with temperature-stabilizing properties, with temperature
control modules made of a phase change material, for example, being
inserted into the transport or freight packaging and the transport
or freight packaging being provided with a thermal insulation
layer. The transport or freight packaging can contain temperature
sensors with which compliance with a predetermined temperature
window can be checked. The transport or freight packaging can also
be designed to protect the secondary packaged products from
mechanical impact.
[0004] When transporting pharmaceuticals over periods of several
hours or days, specified temperature ranges must be adhered to
during storage and transport in order to ensure the usability and
safety of the transported goods. For various drugs, temperature
ranges from 2 to 25.degree. C., in particular 2 to 8.degree. C. or
15 to 25.degree. C., are specified as storage and transport
conditions.
[0005] The problem here is that the pharmaceutical products can
only be stored and transported in a temperature-controlled manner
if they are in the transport or freight packaging, for example in a
temperature-controlled freight container. It can therefore not be
determined whether a secondarily packaged pharmaceutical product
was outside the specified temperature window before it was placed
in the transport or freight packaging or after it was removed from
the transport or freight packaging. For example, in the case of a
temperature-sensitive pharmaceutical product purchased in a
pharmacy, an end user cannot determine whether the product has
become too warm or too cold when being transported home from the
pharmacy. Neither can it be determined in the course of storage in
the secondary packaging at the end user's home, or in a hospital or
pharmacy, whether the product has become too warm or too cold.
[0006] Another disadvantage of conventional packaging systems that
can be mentioned is that it is not possible to determine with
certainty whether the secondary packaging has been opened and the
pharmaceutical product has been replaced by a counterfeit.
[0007] Furthermore, it is not possible to trace the path of the
individual secondary packaged products. If the usual logistics
systems are appropriately equipped, this is only possible with the
shipping unit having the transport or freight packaging, for
example transport pallet, but this does not allow any
differentiation with regard to each individual secondary
packaging.
[0008] It follows from the problems outlined above that the end
user cannot be sure whether he has taken a medically or
pharmaceutically functional drug or whether the effectiveness has
already been impaired due to the effects of temperature.
Furthermore, the consumer cannot ensure whether he has actually
taken the original drug or a fake.
[0009] Due to these uncertainties, it is not permitted in most
countries to send medication from the manufacturer or an
intermediary directly to the end user, as the end user is unable to
check the authenticity and functionality of the medication.
[0010] The invention therefore aims to develop packaging for
pharmaceutical products of the type mentioned at the outset in such
a way that the effectiveness of temperature-sensitive
pharmaceutical products is ensured for the end user and compliance
with a prescribed temperature window can be checked over the entire
transport chain to the end user. The invention also aims to make
counterfeits of pharmaceutical products of any kind
identifiable.
[0011] In order to achieve these objects, the invention essentially
consists in a packaging of the type mentioned at the outset in that
the primary packaging is arranged in an insulation shell having a
latent heat storage material.
[0012] The invention is based on the idea of arranging the
temperature-stabilizing elements inside a secondary packaging so
that compliance with the prescribed temperature window does not
depend on the temporary transport or freight packaging, such as a
refrigerated freight container, a refrigerated transport vehicle or
the like.
[0013] The secondary packaging is that cardboard packaging which is
intended for handling by the end user and which contains the
primary packaging for receiving one dose or several doses of the
pharmaceutical product. The secondary packaging is used to sell the
contained product, which is why it is also referred to as sales
packaging. It can be designed for advertising purposes in order to
encourage the end customer to purchase the respective content.
Compared to the primary packaging such as glass bottles or
blisters, the secondary packaging has no direct contact with the
actual product. Nevertheless, the process steps in the production
of the secondary packaging are usually subject to GMP (Good
Manufacturing Practice) or FDA compliance. Furthermore, in
accordance with the relevant pharmaceutical regulations, the
secondary packaging must provide consumers with initial information
such as the name of the pharmaceutical product, the active
ingredient, the dosage form, the strength of the dosage form, the
batch number, the expiry date and the like.
[0014] The cardboard box forming the secondary packaging is
preferably designed as a folding box. The cardboard box, in
particular cardboard folding box, is preferably constructed from
single or multi-layer cardboard and has a wall thickness of a
maximum of 1 mm, preferably a maximum of 0.5 mm.
[0015] The primary packaging is preferably designed as a blister
pack, ampoule, injection ampoule or vial.
[0016] When equipping the secondary packaging with the temperature
stabilization function, the challenge lies in the very limited
space available and the high cost pressure, as each individual
packaging must be equipped with the technology. The invention
retains the conventional concept of a cardboard box as secondary
packaging and integrates a temperature stabilization element in the
form of a latent heat storage material that surrounds the inner
packaging as an insulation shell.
[0017] It is preferably provided within the scope of the invention
that the temperature stabilization function is implemented by
elements that are located within the secondary packaging, so that
the external appearance of the secondary packaging remains
unchanged.
[0018] Latent heat storage materials belong to the group of passive
temperature control elements, which are characterized by the fact
that they do not require an external energy supply during use, but
instead use their heat storage capacity, whereby depending on the
temperature level, heat is released or absorbed to or from the
primary packaging including the pharmaceutical product to be
temperature-controlled. Such passive temperature control elements
are exhausted as soon as the temperature equalization with the
primary packaging or with its interior is complete. Latent heat
accumulators are a special form of passive temperature control
elements that can store thermal energy in phase change materials
whose latent heat of fusion, heat of solution or heat of absorption
is significantly greater than the heat that they can store due to
their normal specific heat capacity.
[0019] A particularly efficient temperature stabilization is
preferably achieved in that the insulation shell surrounds the
primary packaging on all sides.
[0020] As an additional barrier against changes in temperature of
the pharmaceutical product, a preferred embodiment of the invention
provides that the insulation shell comprising the latent heat
storage material is held in the secondary packaging at a distance
from the secondary packaging on all sides in order to form an
insulation gap. The insulation gap is preferably filled with air,
so that the heat transfer between the primary packaging and the
secondary packaging is considerably reduced at low cost.
[0021] The latent heat storage material preferably contains or is
formed by a phase change material. Phase change materials have a
latent heat of fusion that is significantly greater than the heat
that they can store due to their normal specific heat capacity.
Phase change materials therefore lose their effect as soon as all
of the material has completely passed through the phase change.
However, by executing the opposite phase change, the latent heat
storage can be recharged.
[0022] Depending on the type of pharmaceutical product, it must be
kept in a temperature range from 2 to 20.degree. C., e.g. in a
temperature range from 2 to 8.degree. C. or in a temperature range
from 15.degree. C. to 25.degree. C. The phase change material has a
phase transition temperature that is matched to the prescribed
temperature range.
[0023] The phase change material preferably has a phase transition
temperature of 3-10.degree. C., in particular approx. 5.degree.
C.
[0024] The phase change material is preferably selected from the
group consisting of paraffin, for example n-tetradecane or
n-hexadecane, esters, for example methyl esters, linear alcohols,
ethers, organic anhydrides, salt hydrates, water-salt mixtures,
salt solutions and/or water-based solutions, or mixtures
thereof.
[0025] Conventional phase change materials undergo a phase change
from the solid state to the liquid state and vice versa. The phase
change material must therefore be arranged in a suitable container
so that it also remains in its intended location in the liquid
state. In this context, a preferred embodiment of the invention
provides that the phase change material is present in a
dimensionally stable enclosure, in particular a plastic enclosure.
The dimensionally stable enclosure, including its contents,
preferably forms the insulation shell and therefore completely
surrounds the primary packaging.
[0026] The arrangement of the phase change material in a suitably
suitable enclosure is, however, associated with a high level of
effort and also entails the risk that the phase change material
diffuses through the enclosure or emerges from the enclosure due to
a leak and contaminates the primary packaging. Furthermore, one is
restricted in the shape of the enclosure, which in turn makes it
difficult to handle when arranging the insulation shell in the
secondary packaging and requires more space and weight.
[0027] In order to avoid these disadvantages, a preferred
development of the invention provides that the latent heat storage
material comprises a carrier material which is dimensionally stable
at the use temperature, in which the phase change material is
distributed or arranged so that the latent heat storage material is
dimensionally stable in a temperature range both below and above
the melting point of the phase change material. The use temperature
is understood here to be the temperature at which an end user
applies, transports or stores the pharmaceutical product. The use
temperature therefore preferably covers a temperature range from
-25.degree. C. to +60.degree. C. Thereby the problems with the
handling of the phase change material can be avoided. In
particular, it is not necessary to arrange latent heat accumulators
of this type in separate containers.
[0028] The carrier material here forms a matrix or a
three-dimensional network in which the phase change material is
distributed. The matrix or the network consisting of the carrier
material gives the latent heat storage device the required
mechanical stability at the use temperature and does not itself
show any phase change within the use temperature.
[0029] In addition to the phase change material, the latent heat
storage element preferably comprises one or more copolymers, in
particular styrene block copolymers, and/or ethylene-butylene
copolymers, as a carrier material, in order to ensure the
dimensional stability of the latent heat storage element above the
melting point of the phase change material.
[0030] Nanoporous carbon, into which the phase change material is
incorporated, can also be used as the carrier material.
Furthermore, small-pore lattice structures made of a polymer or
open-pore foams, such as synthetic resin foams based on crude oil
or the like, can be used as the carrier material.
[0031] It is preferably provided that the latent heat storage
material is dimensionally stable up to a temperature of 10.degree.
C., preferably 20.degree. C., particularly preferably 40.degree. C.
above the phase transition temperature of the phase change
material. This ensures that the latent heat storage element
continues to be dimensionally stable even at higher
temperatures.
[0032] It can preferably be provided that the latent heat storage
material, with a corresponding configuration of the carrier
material, can be converted into the molten state when heated to a
temperature well above the use temperature. The transition to the
molten state can in particular take place from a temperature which
is at least 60-100.degree. C. above the use temperature or room
temperature (20.degree. C.). This enables the insulation shell to
be produced by means of a forming process, in particular a casting
process.
[0033] A preferred embodiment provides that the insulation shell is
produced by injection molding the latent heat storage material.
Injection molding processes have been known for a long time and can
therefore be used easily and safely. In particular, injection
molding processes can also be used to produce complex shapes in a
simple and cost-effective manner.
[0034] According to a preferred embodiment, the insulation shell is
adapted to the shape of the primary packaging and lies preferably
flat, in particular on all sides, on the primary packaging. This
allows a particularly efficient temperature stabilization of the
primarily packaged product. The planar contact of the insulation
shell with the primary packaging also includes embodiments in which
a separating layer, for example in the form of a plastic film, is
arranged between the shape-adapted insulation shell and the primary
packaging. The shape-adapted design of the insulation shell is
achieved in a particularly simple manner by using a casting or
injection molding process.
[0035] In particular, the insulation shell can be molded onto the
primary packaging. This is particularly advantageous when the
primary packaging is designed as an ampoule or vial. The insulation
shell is then applied by using the ampoule or vial as a carrier for
the injection molding process, i.e. the latent heat storage
material is sprayed directly onto the primary packaging or the
primary packaging is encased with latent heat storage material.
[0036] The use of a dimensionally stable latent heat storage
material offers the further advantage that the insulation shell can
serve as additional protection for the primary packaging against
mechanical impact. Depending on the rigidity, the latent heat
storage material can also be used as a shock absorber and protect
the primary packaging, which is made of glass, for example, if the
packaging falls to the floor, for example. The rigidity of the
latent heat storage material can be optimally adapted to the
product, since dimensionally stable latent heat storage materials
with a high modulus of elasticity of up to 3000 N/mm.sup.2 or with
a very low modulus of elasticity of up to 1 N/mm.sup.2 can be
produced. In the variant in which a phase change material is poured
in liquid form into a plastic shell, the additional mechanical
protection can take place via the rigidity of the plastic
shell.
[0037] In the variant in which the phase change material is
distributed in a matrix or a network of a carrier material that is
dimensionally stable both above and below the melting point of the
phase change material, the carrier material can impart
impact-absorbing properties to the latent heat storage element. For
this purpose, the carrier material is preferably selected in such a
way that the modulus of elasticity of the insulation shell is
<1000 N/mm.sup.2, preferably 10-100 N/mm.sup.2. For example, the
carrier material can be selected from the group of elastomers.
[0038] The insulation shell can preferably consist of at least two
layers, which particularly preferably have phase change materials
with different phase transition temperatures. This allows the
desired temperature range to be set easily and efficiently.
[0039] The insulation shell can be formed from two half parts or
from a plurality of parts which together enclose the primary
packaging.
[0040] The insulation gap is preferably delimited on the outside by
the cardboard box and on the inside by the insulation shell. In
order to obtain particularly good thermal insulation of the
pharmaceutical product, it is preferably provided that the
insulation gap is filled with a gas, such as, for example, with
air, CO.sub.2, krypton, xenon or a mixture of these gases, or is
evacuated.
[0041] The insulation gap preferably has a thickness of <16 mm,
in particular 5-10 mm. With a 10 mm thick insulation gap, the heat
conduction of the air in the gap is approx. 2.6 W/m.sup.2K. As
measurements have shown, the heat transfer coefficient at the
interface between the outer packaging and the air in the insulation
gap or between the insulation shell and the air in the insulation
gap is approx. 3-5 W/m.sup.2K. With a gap width of less than 5 mm,
the relevant insulating effect, due to the two heat transfer
coefficients of the surfaces adjacent to the air gap, is no longer
created via the air. The insulation gap can preferably also have a
thickness of <5 mm, in particular 1-3 mm.
[0042] The insulating performance of the insulation gap can be
further improved by coating the two surfaces delimiting the gap, or
even just one of the surfaces, with a heat-reflective coating.
[0043] A preferred embodiment therefore provides that the
insulation shell has a heat-reflecting coating, such as a metallic
coating or a metal foil, on its outside.
[0044] Alternatively or additionally it can be provided that the
cardboard box has a heat-reflecting coating on its inner surface,
such as a metallic coating or a metal foil.
[0045] Preferably, the heat-reflecting coating is formed of a
metallic, in particular gas-tight coating, preferably a coating
with an emissivity of <0.5, preferably <0.2, particularly
preferred <0.04, such as a coating made of aluminum.
[0046] The coating allows the energy transfer due to thermal
radiation to be significantly reduced and the insulation
performance is increased without a significant increase in
costs.
[0047] The insulation performance can be further increased by
filling the insulation gap with additional layers of reflective
foils, or by removing the gas from the insulation gap (vacuum).
Alternatively, the insulation gap can be filled with a highly
insulating material such as an airgel.
[0048] In order to further improve the insulating effect of an
insulation gap filled with a gas, it is preferably provided that
the insulation gap is subdivided by at least one intermediate
layer, preferably a film, arranged in the insulation gap. The at
least one intermediate layer is preferably arranged essentially
parallel to the outer and inner surfaces delimiting the insulation
gap. If the thickness of the insulation gap is too great,
undesirable convection can take place within the insulation layer.
In order to prevent this, the at least one intermediate layer
divides the insulation gap into at least two areas, each with a
smaller thickness. The intermediate layer can preferably be
provided with heat-reflecting properties on one or both sides, in
particular with a heat-reflecting coating. The heat-reflecting
coating is preferably formed of a metallic, in particular gas-tight
coating, preferably a coating with an emissivity of <0.5,
preferably <0.2, particularly preferred <0.04, such as a
coating made of aluminum.
[0049] At least one layer, in particular several superimposed
layers, of a heat-reflecting film, in particular metal foil, is
particularly preferably arranged in the insulation gap.
[0050] According to a preferred embodiment, the insulation gap is
created by arranging spacer elements, in order to keep the
insulation shell in the secondary packaging at a distance from the
secondary packaging on all sides.
[0051] The spacer elements can be made up of separate parts that
are distributed around the insulation shell and are arranged
between the insulation shell and the secondary packaging, the
contact surfaces of the spacer elements on the insulation shell and
the cardboard box being minimized in order to reduce the transfer
of heat through conduction.
[0052] The spacer elements preferably consist of the phase change
material of the insulation shell or are formed from cardboard
elements, in particular cardboard elements of the secondary
packaging.
[0053] In order to be able to monitor compliance with the
prescribed temperature range and/or to be able to detect
inadmissible opening of the secondary or primary packaging for the
purpose of introducing a counterfeit, a preferred development
provides that a temperature sensor or a temperature control strip
is arranged in the insulation gap, in the latent heat storage
material, between latent heat storage material and primary
packaging or in the primary packaging. Temperature control strips
are a type of chemical paper thermometer in which a measuring strip
changes its color irreversibly when it reaches a predetermined
temperature.
[0054] Furthermore, in this context, an electronic memory can be
provided in the packaging for storing temperature measurement
values recorded at regular intervals or continuously, the
electronic memory preferably being connected to an electronic
circuit for wirelessly reading out the stored temperature
measurement values. For example, the stored temperature measurement
values can be fed to an antenna for wireless inductive transmission
of the values to a reading device. The data can be transmitted
using the RFID or NFC standard, for example.
[0055] The temperature sensor is preferably arranged between the
primary packaging and the secondary packaging or within the
insulation shell. In the case of the arrangement within the
insulation shell, the temperature measurement can be used to
determine whether it has been opened. Without opening the
insulation shell, there cannot be a sudden rise in temperature.
When the insulation shell is opened, there is inevitably a jump in
temperature, since the outside temperature cannot be adjusted to,
for example, 0.1K of the inside temperature before opening, as the
inside temperature is not known to a third party. It can thus be
ensured that an exchange of the pharmaceutical product is
automatically recognized by a system.
[0056] The invention is explained in more detail below with
reference to exemplary embodiments shown schematically in the
drawing. FIG. 1 shows a perspective view of the packaging according
to the invention and FIG. 2 shows a cross section of the packaging
according to FIG. 1.
[0057] In FIGS. 1 and 2, a cardboard box is denoted by 1, which
represents the secondary packaging. In the interior of the
cardboard box 1, an insulation shell 2 is arranged, which consists
of a latent heat storage material or contains such a material. The
insulation shell encloses a primary packaging 3, which is designed,
for example, as a glass ampoule, which holds a pharmaceutical
product in its interior 4. The insulation shell 2 can consist, for
example, of two half-shells which can be separated from one another
along a separation plane 5 in order to make the primary packaging 3
accessible. As can be seen in FIG. 2, the insulation shell is
adapted to the outer shape of the primary packaging 3, so that the
insulation shell 2 rests flat against the primary packaging 3, in
the present case along a cylindrical surface.
[0058] Between the insulation shell 2 and the cardboard box 1,
spacer elements 6 are arranged on all sides, i.e. on all six sides
of the cuboid, which ensures that an insulation gap 7 is provided
between the insulation shell 2 and the cardboard box 1. However,
the insulation gap 7 can also be dispensed with. The insulation gap
7 is filled with a gas, such as air. To improve the thermal
insulation, a heat-reflecting coating 8 or 9, for example in the
form of a metal foil, can be applied to the outside of the
insulation shell 2 and/or to the inside of the cardboard box 1. A
heat-reflecting planar element, for example a metal foil, can also
be arranged in the insulation gap 7, as is indicated by way of
example with the dashed line 10 in the area between the two
right-hand spacer elements 6.
[0059] To control the temperature of the pharmaceutical product, a
temperature sensor 11 is also provided, which is directed towards
the separation plane 5 if the insulation shell 2 is formed from two
half-shells. The temperature sensor 11 can not only monitor the
temperature of the pharmaceutical product, but also detect an
unauthorized opening of the packaging. If the two half-shells of
the insulation shell are separated from one another, the
temperature detected by the temperature sensor 11 changes
suddenly.
* * * * *